8 results
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50ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
FDA Enforcement
Class II
·Terminated·Ellex iScience, Inc.·October 10, 2018
ITRACK 250A
FDA Adverse Event
Malfunction
·ELLEX ISCIENCE INC.·Product code MPA·August 19, 2014
ITRACK 250A
FDA Adverse Event
Malfunction
·ELLEX ISCIENCE, INC.·Product code MPA·August 19, 2014
ITRACK 250A
FDA Adverse Event
Malfunction
·ELLEX ISCIENCE, INC·Product code MPA·September 3, 2014
ITRACK 250A
FDA Adverse Event
Injury
·ELLEX ISCIENCE INC.·Product code HMX·May 9, 2019
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
FDA Recall
Terminated
·Ellex iScience, Inc.·Product code HMX·January 11, 2018
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
FDA Recall
Terminated
·Ellex iScience, Inc.·Product code HMX·August 6, 2014
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
FDA Enforcement
Class II
·Terminated·Ellex iScience, Inc.·September 10, 2014